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Learning Objectives Identify patients at high risk for osteoporotic fracture Individualize risk assessment including use of the WHO FRAX ® tool Discuss general measures to optimize calcium, vitamin D, and exercise Evaluate the different pharmacologic therapies to match the patient’s clinical situation Utilize different modalities to improve adherence and compliance with treatment plan

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Osteoporosis Systemic skeletal disorder of compromised bone strength increased risk of fracture –34 million Americans: low bone mass –10 million Americans: osteoporosis 1 in 2 women and 1 in 4 men >age 50 will have an osteoporosis-related fracture in their lifetime By 2020, 1 in 2 Americans >age 50 will be at risk for fractures from osteoporosis or low bone mass US Department of Health and Human Services. Bone Health and Osteoporosis: A Report of the Surgeon General. Rockville, MD: US Department of Health and Human Services, Office of the Surgeon General; Available at: Accessed September 13, 2013.

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2 million bone breaks a year (“2 million 2 many”) 1 Only 2 in 10 patients with osteoporosis get a follow-up test or treatment for osteoporosis 1 Fractures may have serious consequences 2 –Hip fracture 10%-20% additional mortality per year 20% of hip fracture patients require long-term nursing home care Only 40% fully regain their pre-fracture level of independence 1 Fracture Facts! 1. National Bone Health Alliance. 2 Million 2 Many. Available at: Accessed September 13, US Department of Health and Human Services. Bone Health and Osteoporosis: A Report of the Surgeon General. Rockville, MD: US Department of Health and Human Services, Office of the Surgeon General; Available at: Accessed September 13, 2013.

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Majority of Fractures Occur in Patients With Osteopenia, Not Osteoporosis! Why? Osteopenia patients outnumber those with osteoporosis 3:1 Fracture risk—determined by more than just BMD Clinical factors such as age, lifestyle, and family and personal medical history also play a role Implications Appropriate treatment depends on being able to accurately determine the risk of future fractures Davey DA. S Afr Med J. 2012;102:

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10-year risk of fractures: ≥3% for hip fracture or ≥20% for a major osteoporotic fracture T-scores between -1.0 and -2.5 and NOF Guidelines 2010: Whom to Treat After exclusion of secondary causes, treat postmenopausal women and men age 50 and older who have… Osteoporosis Clinical diagnosis: Hip or spine fracture DXA diagnosis: T-score -2.5 or below in the spine or hip National Osteoporosis Foundation. Clinician’s Guide to Prevention and Treatment of Osteoporosis. Washington, DC: National Osteoporosis Foundation; Available at: Accessed September 13, 2013.

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FRAX ® Statistically robust fracture risk prediction tool developed by the WHO for world-wide use Combines BMD + clinical risk factors to predict fracture risk better than either alone Predicts the 10-year probability of major osteoporotic fracture –Hip, spine, wrist, or humerus Use when the decision to treat is uncertain WHO FRAX ® Tool. Accessed September 13, 2013.

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Benefits of FRAX ® Treatment decisions in osteopenic patients clearer –Decision is based on the risk of fracture, not T-score alone Identifies patients at high-risk for fractures to ensure that they are offered treatment to lower their risk Helps avoid giving medication to those who are at low risk and have little to gain from treatment National Osteoporosis Foundation. Clinician’s Guide to Prevention and Treatment of Osteoporosis. Washington, DC: National Osteoporosis Foundation; Available at: Accessed September 13, “Specific treatment decisions must be individualized”

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Increased bone density in the spine by 5% to 8% and at the hip by 3% to 6% after 3 years Reduced incidence of vertebral fractures by 40% to 70% Alendronate, risedronate and zoledronic acid reduced non-vertebral fractures (25% to 40%), including hip fractures (40% to 60%), in women with osteoporosis Ibandronate: Overall, no effect observed on non-vertebral or hip fractures. In a post-hoc analysis, non-vertebral fracture reduction was seen in a high-risk subgroup with a baseline femoral neck T-score less than -3.0 Bisphosphonates: Effects Alendronate, Risedronate, Ibandronate and Zoledronic Acid

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Contraindications/Warnings/Precautions –Hypocalcemia –Creatinine clearance <30 cc/min (<35 cc/min for zoledronic acid) –For oral dosing: Esophageal stricture or impaired esophageal motility (alendronate); inability to stand or sit for at least 30 minutes (alendronate/risedronate) or 60 minutes (ibandronate) Notes: UGI symptoms per se are not a contraindication to oral dosing. Use in pregnancy: Class C Oral dosing requirements –Tablets (with exception of delayed release risedronate) taken on an empty stomach after overnight fast with 6 to 8 oz of plain water while in an upright position –Patients should not eat or lie down for at least 30 minutes (alendronate and risedronate) or 60 minutes (ibandronate) –Calcium and vitamin D supplements, if needed, should be taken at a different time of day than the oral bisphosphonate Bisphosphonates National Osteoporosis Foundation. Med Lett. 2011;53(1360):24.

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The right medication for the right patient at the right time Susceptibility to side effects –Past history of DVT – no estrogen or raloxifene –Esophageal stricture – use of IV bisphosphonates or denosumab Dosing/convenience Adherence Treatment Considerations

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This winter, Sharon slipped on wet leaves and fell on the grass, fracturing her wrist How does the current fracture impact on clinical decision-making? Should Sharon have an updated DXA? Should any laboratory tests be requested? Sharon – Updated Medical History

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Sharon Sharon’s laboratory tests are normal She considers her individualized risk, and chooses an antiresorptive agent Sharon does fairly well with her once- weekly agent for the first 3 months She fails to refill her prescription for several weeks Over the next several months, she often misses her weekly dose

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Impact of Lack of Patient Education Did not always give them adequate information about their medications Did not communicate this information in a format that was easy to comprehend Lau E, et al. Can Fam Physician. 2008;54: In Canadian study of postmenopausal osteoporotic patients said their doctors Lack of communication with the HCP was perceived to be a major factor affecting adherence

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Side Effects and Adherence Discuss side effects of the medicines Put into perspective of risk vs benefits Reiterate patient's high risk of fracture Address other information sources (media, Internet, friends) –May deter from starting –Encourage to stop use